BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 20D LINER 28IDX58OD

    MDR report key: 2872077 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-83655
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED TO ADDRESS POLY WEAR AND DISLOCATION. DOI (B)(6) 2000 - DOR (B)(6) 2012 (RIGHT HIP). UPDATE 1/14/2013 - MEDICAL RECORDS AND X-RAYS WERE RECEIVED. NO NEW INFORMATION WAS RECEIVED THAT WOULD CHANGE THE EXISTING MDR DECISION ON THIS COMPLAINT; HOWEVER, A NEW COMPLAINT WAS INITIATED TO REPORT A PREVIOUS REVISION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. MEDICAL RECORDS AND X-RAYS WERE OBTAINED. PER A REVIEW OF THE PROVIDED MEDICAL RECORDS THE MATERIAL WEAR OVER TIME MAY HAVE CONTRIBUTED TO INSTABILITY / DISLOCATION. THE PATIENT IS NOTED TO BE OBESE. POLY MATERIAL WEAR AFTER THIS LENGTH OF TIME IMPLANTED WOULD NOT BE UNREASONABLE TO EXPECT. IT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED, THAT THE COMPLAINT IS PRODUCT RELATED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR 20D LINER 28IDX58OD ACETABULAR LINER JDL DEPUY ORTHOPAEDICS, INC. UN5D61003

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other